Clearance Summary
SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025 received FDA 510(k) clearance under submission number K083802, sponsored by Medi-Globe Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2009-03-20.
- Submission: K083802
- Applicant / Sponsor: Medi-Globe Corporation
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1075
- Decision date: 2009-03-20
Classification & Regulation
This clearance is catalogued under FDA product code FCG and 21 CFR 876.1075, within the Gastroenterology, Urology review panel as a Class II device.